The U.S. Food and Drug Administration approves the first ever medical device for the treatment of attention deficit hyperactivity disorder.
The device is called the Monarch external Trigeminal Nerve Stimulation, which is indicated for kids between 7 to 12 years old.
Also known as Monarch eTNS, this device is the pioneer non-drug therapy against ADHD that was able to get the marketing authorization nod from the FDA.
"This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind," says Carlos Peña, Ph.D., director of the Division of Neurological and Physical Medicine Devices in the FDA's Center for Devices and Radiological Health.
What Exactly Is This Device?
Monarch eTNS produces a mild electrical impulse, which is subsequently sent to the branches of the trigeminal nerve. The impulse then travels to the regions of the brain that are known to be involved in ADHD, creating therapeutic signals.
The device is designed to be operated at home, as supervised by a caregiver. The person administering Monarch eTNS sets it up by putting a small patch, which is connected to the actual apparatus, on the patient's forehead, just above the eyebrows. The therapy is performed during sleep, and patients are expected to feel a tingling sensation on the skin.
Results are expected after about four weeks of treatment. At this time, patients are advised to follow up with their health care provider to evaluate treatment effects.
Neuroimaging examinations of kids who used Monarch eTNS show promise, as manifested by increased activity of brain areas that are recognized to be vital in regulating behavior, emotion, and attention. The exact mechanism of Monarch eTNS, however, remains unknown.
In the clinical trial for Monarch eTNS, scientists examined 62 children diagnosed with moderate to severe ADHD. The participants either used the therapy or a placebo device for four weeks.
After the course of the clinical trial, patients who received eTNS showed better improvement of ADHD symptoms.
The evaluators used a clinician-administered test called the ADHD-RS scale, which monitors the frequency and severity of symptoms. A higher score indicates worsening condition.
Patients who received Monarch eTNS managed to drop their ADHD-RS scores from 34.1 to 23.4, at the average. The placebo group also showed a decrease in scores, but the change was lesser with an average drop of 33.7 to 27.5.
FDA's Premarket Approval Scheme
The FDA tested Monarch eTNS via the de novo premarket review pathway, which is intended for low to moderate risk new devices. Similar devices may have to undergo approval through this scheme as well, wherein companies are able to get marketing authorization by showing enough equivalence to a predicate apparatus.
For Monarch eTNS system, FDA granted the marketing approval to NeuroSigma.
Therapy Limitations And Side Effects
While the product sounds really promising, FDA also details the side effects and limitations of using Monarch eTNS.
The device should not be used for children under the age of 7, and for those who are currently taking prescription ADHD medications. It is also not to be administered in patients that have body-worn insulin pump, and active implantable pacemakers or neurostimulators.
The most common side effects of the device are increased sleepiness, increased appetite, difficulty of sleeping, headache, increased tiredness, and teeth clenching.
Families will cost €800 (USD 900) for the kit, and €5 (USD 6) for each additional patch. Neurosigma answers if Monarch eTNS is covered by insurance.
"No, at this time the Monarch is not covered by insurance," answers NeuroSigma in their website.
Peña said this FDA action manifests their serious commitment to working with device companies to further the development of pediatric medical products so kids can have access to modern, safe, and effective therapies that meet their unique needs.